FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
50436-6744
11-digit product format
504366744
Labeler code
50436
Product ID
50436-6744_60ddd1bf-6ff5-442c-9fe8-417ebff5265a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040555
Marketing category
ANDA
Marketing start
2005-04-15
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-6744-12023-01-30C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-22023-01-30C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-32023-01-30C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-42023-01-30C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-12021-08-06C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-22021-08-06C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-32021-08-06C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-42021-08-06C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-12021-01-29C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-22021-01-29C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-32021-01-29C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-42021-01-29C16284748780-1ba0f9c33-3635-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6744-1Phentermine Hydrochloride14 in 1 BOTTLETABLET1410
50436-6744-2Phentermine Hydrochloride7 in 1 BOTTLETABLET710
50436-6744-3Phentermine Hydrochloride30 in 1 BOTTLETABLET3010
50436-6744-4Phentermine Hydrochloride28 in 1 BOTTLETABLET2810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6744-1EA - Each50436-674455ad06ba-cbd5-445d-97ed-b17fc520ea8e12015-10-02
50436-6744-2EA - Each50436-67445ce36a0b-1e72-4b4e-b8a0-336cbb3bae6212015-10-02
50436-6744-3EA - Each50436-67449dbbaf08-bd40-4fe4-94ef-af6418badbc012015-10-02
50436-6744-4EA - Each50436-67440ed2e0a8-4575-4fbd-b742-905ae1fb0b1012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6744PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]10Legacy NDC, 4 package rows20210808_ef061dd2-1b35-49bf-beda-8c9fe02e5f9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNef061dd2-1b35-49bf-beda-8c9fe02e5f9f10
803353phentermine hydrochloride 37.5 MG Oral TabletSCDef061dd2-1b35-49bf-beda-8c9fe02e5f9f10
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYef061dd2-1b35-49bf-beda-8c9fe02e5f9f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-6744-15043667440114 TABLET in 1 BOTTLE (50436-6744-1) 14 tablet2021-08-050000-00-00NoNoCurrent
50436-6744-2504366744027 TABLET in 1 BOTTLE (50436-6744-2) 7 tablet2021-08-050000-00-00NoNoCurrent
50436-6744-35043667440330 TABLET in 1 BOTTLE (50436-6744-3) 30 tablet2021-08-050000-00-00NoNoCurrent
50436-6744-45043667440428 TABLET in 1 BOTTLE (50436-6744-4) 28 tablet2021-08-050000-00-00NoNoCurrent